Overview

Reduced Intensity Conditioning Before Partially Matched Donor Stem Cell Transplant in Treating Patients With Advanced Cutaneous T Cell Lymphoma

Status:
Withdrawn
Trial end date:
2017-03-16
Target enrollment:
0
Participant gender:
All
Summary
This phase I trial studies the side effects and the best dose of donor lymphocyte infusion when given together with reduced intensity conditioning regimen before partially matched donor stem cell transplant in treating patients with stage IIB-IV mycosis fungoides or Sezary syndrome. Giving chemotherapy and low-dose total-body irradiation followed by high-dose cyclophosphamide before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Removing the T-cells from the donor cells and giving them before transplant may stop this from happening. Additionally, giving tacrolimus and mycophenolate mofetil before and after transplant may also stop this from happening.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Treatments:
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
Vidarabine
Criteria
Inclusion Criteria:

1. Stage IIB-IV mycosis fungoides and sezary syndrome who have failed at least one
standard systemic therapy or are not candidates for standard therapy.

2. Patient should have a responsive skin disease including complete remission (CR) and
partial remission (PR) (close to CR; 75%-99% clearance of skin disease from baseline
without new tumors (T3) in patients with T1, T2 or T4 only skin disease) and should
not have visceral organ or lymph node involvement prior to transplantation.

3. Patients must have a related donor who is a two or more allele mismatch at the HLA-A;
B; C; DR and DQ loci. Patients who have sibling donors with a one antigen mismatch due
to recombination will not be enrolled in this protocol.

4. Patients must have adequate organ function:

- Left Ventricular Ejection Fraction (LVEF) of >50%

- Carbon Monoxide Diffusing Capacity (DLCO) >50% of predicted corrected for
hemoglobin

- Adequate liver function as defined by a serum bilirubin <2.0 (unless hemolysis or
Gilbert disease), Aspartate aminotransferase (AST) or Alanine aminotransferase
(ALT) < 2.5 X upper limit of normal

- Creatinine clearance of > 60 ml/min

5. Performance status > 80% (Karnofsky)

6. Hematopoietic Cell Transplantation Specific Comorbidity Index (HCT-CI) <5 for age <
65, HCT-CI <4 for age >65

7. Patients must be willing to use contraception if they have childbearing potential

8. Able to give informed consent, or their legally authorized representative can give
informed consent.

Exclusion Criteria:

1. Performance status of < 80% (Karnofsky)

2. HIV positive

3. Active involvement of the central nervous system with malignancy

4. Psychiatric disorder that would preclude patients from signing an informed consent

5. Pregnancy, or unwillingness to use contraception if they are have childbearing
potential.

6. Patients with life expectancy of < 6 months for reasons other than their underlying
hematologic/oncologic disorder or complications there from.

7. Patients who have received alemtuzumab within 8 weeks of transplant admission, or who
have recently received horse or rabbit anti-thymocyte globulin (ATG) and have ATG
levels of > 2 μgm/ml.

8. Patients who cannot receive cyclophosphamide

9. Patients with evidence of another malignancy (exclusive of a skin cancer that requires
only local treatment);

- Patients with prior malignancies diagnosed> 5 years ago without evidence of
disease are eligible.

- Patients with prior malignancy treated < 5 years ago but have a life expectancy
of > 5 years for that malignancy are eligible.

10. Uncontrolled active infection